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Disposable Syringes (with needle)
EUDAMEDClass IIa (EU MDR)
Ref DS01-25Model 1ml 2ml 5ml 10ml 20ml 30ml 50mlRef DS02-25Ref DS50-21Ref DS10-23
Identity
- Trade Name
- Disposable Syringes (with needle) EUDAMEDDisposable Syringes(with needle) EUDAMED
- Device Name
- Disposable Syringes (with needle) EUDAMED
- Model / Reference
- 1ml 2ml 5ml 10ml 20ml 30ml 50ml EUDAMEDDS01-25 EUDAMEDDS02-25 EUDAMEDDS50-21 EUDAMEDDS10-23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603582795 EUDAMED06971603582825 EUDAMED06971603583549 EUDAMED06971603583150 EUDAMED
- Basic UDI-DI
- 697160358WDSW/NT5 EUDAMED
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Syringes (with needle) by Shantou Wealy Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697160358WDSW/NT5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020619
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 1ff283be-9079-4847-b702-94be7ddeb39e 61 fields · synced Oct 6, 2026
- EUDAMED 00ee49c8-9aea-40f2-9422-862a8993e67b 61 fields · synced May 18, 2026
- EUDAMED 8a60bd78-7d95-415d-8cfc-588e715fa826 61 fields · synced May 18, 2026
- EUDAMED d3f7c046-5c12-4131-bd70-069b9d204fae 61 fields · synced Jul 13, 2026